Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression
Latest Information Update: 01 Aug 2024
At a glance
- Drugs Ketamine (Primary) ; Cycloserine/lurasidone
- Indications Bipolar depression; Suicidal ideation
- Focus Registrational; Therapeutic Use
- Acronyms SevereBD
- Sponsors NeuroRX; NRx Pharmaceuticals
- 29 Jul 2024 According to a NRx Pharmaceuticals media release, NRx remains on track to file the NDA for NRX-100 in Q4 2024 with anticipated PDUFA date in Q2 2025.
- 08 Apr 2024 According to a NRx Pharmaceuticals media release, the Company has also announced plans to submit a New Drug Application to FDA this quarter for the use of ketamine as a short-term therapy for suicidal bipolar depression.
- 28 Mar 2024 According to a NRx Pharmaceuticals media release, the company anticipates filing of New Drug Application for treatment of Acute Suicidality by June 2024 upon completion of required 9 month stability and CMC with anticipated 2024 PDUFA date.